FDA
inspections in pharmaceutical manufacturing units is being critical these days
and it seems that it will be more critical in future because FDA is focusing
more on product quality as well as its documentation.

Document
fabrication particularly in Indian pharmaceutical companies is a common issue. Therefore,
FDA has changed their inspection strategies to sudden inspection without prior
notification or very short notification period. At this condition manufacturers
have to be always prepared for a FDA inspection.

Before
planning a FDA audit everyone should know what FDA inspectors want to find
during their inspections. Howard Sklamberg, FDA’s Deputy Commissioner said in FDA Voice, “FDA inspections ensure that when a firm wants to export drugs to
the United States, the drugs meet FDA standards and will be of the quality
patients and consumers want and deserve.”

FDA also
says that they want not only to inspect the product quality but also to enhance
the “quality culture” in pharmaceutical manufacturing firms. “Quality culture”
explains the vision and demand of FDA inspectors very clearly. FDA wants
quality not only in product but also in everything – in product, documents, facility,
trainings, behavior, and dresses also. It is easy to manufacture a quality
product in a facility having quality in its culture and working. The personnel
working in facility should quality conscious and should not compromise with
product quality. FDA inspectors also focus on the quality of the equipment and
instruments used in facility to understand the quality policies of the
manufacturers.

Manufacturers
particularly in India must focus to develop a quality culture in manufacturing
and quality control of facility. It will help them to face the FDA inspection easily
and avoid issuance of form 483s and warning letters particularly in surprise audits.